Ambroxol 30

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AMBROXOL 30 (AMBROXOL 30)

Composition:

Active ingredient: ambroxol hydrochloride;

5 ml of syrup contain 30 mg of ambroxol hydrochloride (calculated as 100 % dry substance);

Excipients: benzoic acid (E 210), sucralose, hydroxyethyl cellulose, banana flavor, vanilla-cream flavor, purified water.

Pharmaceutical form. Syrup.

Main physico-chemical properties: colorless or slightly yellowish clear liquid with a characteristic odor.

Pharmacotherapeutic group. Drugs used for cough and colds. Mucolytic agents. Ambroxol. ATC Code R05C B06.

Pharmacological properties.

Pharmacodynamics.

Ambroxol increases secretion of the respiratory tract glands, stimulates ciliary activity of the respiratory tract, enhances surfactant production in the lungs. These effects lead to improved mucus clearance and expectoration (mucociliary clearance). Activation of fluid secretion and increased mucociliary clearance facilitate mucus elimination and reduce coughing.

Pharmacokinetics.

The effect of the drug begins within 30 minutes after administration and lasts about 10 hours.

Absorption of the drug is rapid and sufficiently complete. Maximum plasma concentrations are reached within 0.5–3 hours. The extent of ambroxol binding to plasma proteins is 80–90%.

Distribution of ambroxol from blood to tissues is rapid, with high concentrations of the active substance in the lungs. The drug penetrates through the blood-brain and placental barriers, and into breast milk.

Ambroxol is metabolized in the liver via conjugation. The elimination half-life from plasma is 10 hours; accumulation has not been observed. Approximately 90% is excreted by the kidneys in the form of water-soluble metabolites, and 5% in unchanged form. The elimination half-life is prolonged in severe chronic renal insufficiency.

Clinical characteristics.

Indications.

Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with impaired bronchial secretion and weakened expectoration of sputum.

Contraindications.

• Hypersensitivity (allergy) to ambroxol or to other components of the drug.

Interaction with other medicinal products and other types of interactions.

Concomitant use of ambroxol with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) promotes increased antibiotic concentrations in lung tissue.

Concomitant use of Ambroxol 30 with antitussive agents may impair sputum expectoration due to reduced coughing. Therefore, such combination should be used only after careful evaluation by a physician of the benefit-risk ratio.

Special precautions for use

When using mucolytic agents such as ambroxol hydrochloride, isolated cases of severe skin reactions have been reported, including erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), and acute generalized exanthematous pustulosis. These reactions were mostly attributable to the severity of the underlying disease and/or concomitant therapy. Additionally, during the initial stages of Stevens-Johnson syndrome or Lyell's syndrome, patients may present with influenza-like nonspecific prodromal symptoms such as fever, body aches, rhinitis, cough, and sore throat. Due to misinterpretation of these symptoms, patients might have received medications for symptomatic treatment of cough and cold. Therefore, if progressive skin lesions appear (sometimes associated with blistering or mucosal involvement), the drug should be discontinued immediately and medical help should be sought.

The medication should be used with caution in patients with gastric or duodenal ulcer.

In cases of renal impairment or severe liver disease, Ambroxol 30 should be used only after consultation with a physician; the dosing intervals may need to be prolonged or the dose reduced. Ambroxol hydrochloride is metabolized in the liver and excreted via the kidneys. Therefore, in severe renal insufficiency, accumulation of ambroxol and/or its metabolites in the body may occur.

During treatment, it is necessary to consume sufficient fluids (juices, tea, water) to enhance the mucolytic effect of the drug.

Ambroxol 30 is sugar-free and contains no alcohol.

Concomitant use of Ambroxol 30 with antitussive agents may impair expectoration due to cough suppression.

Mucolytic agents (including ambroxol) should be used with caution in conditions associated with increased mucus secretion and impaired bronchial motility (e.g., in rare genetically determined disorders such as primary ciliary dyskinesia) due to the risk of excessive mucus accumulation.

Use during pregnancy or breastfeeding

Pregnancy

Ambroxol hydrochloride crosses the placental barrier. Clinical studies on the use of ambroxol hydrochloride have not shown any harmful effects on the fetus after the 28th week of pregnancy. Nevertheless, standard precautions for drug use during pregnancy should be observed. Particularly, the use of the drug is not recommended during the first trimester of pregnancy.

Breastfeeding

Ambroxol hydrochloride passes into breast milk; therefore, the drug is not recommended during breastfeeding.

Fertility

Preclinical studies have not shown any direct or indirect harmful effects on fertility.

Ability to influence reaction rate while driving or operating machinery

Not described.

Method of administration and dosage.

For adults and children aged 12 years and older: 10 mL (2 measuring spoons) twice daily, equivalent to 120 mg of ambroxol hydrochloride per day.

The medication can be taken during meals or independently of food intake. Food does not affect the drug's efficacy.

The treatment duration for acute respiratory tract diseases and initial treatment of chronic conditions is up to 14 days. A doctor should be consulted if symptoms persist beyond 14 days or worsen despite treatment.

The dosing regimen with the highest dose should be used during initial treatment; the dose may be reduced by half after 14 days of treatment with the drug.

Children.

For children under 12 years of age, use Ambroxol 15.

Overdose.

Specific symptoms of ambroxol overdose are currently unknown. In case of accidental overdose and/or incorrect use, symptoms corresponding to the adverse effects of ambroxol hydrochloride may occur. Treatment is symptomatic.

Side effects.

The drug is well tolerated by patients.

Gastrointestinal tract: dyspepsia, heartburn, nausea, vomiting, abdominal pain, diarrhea/constipation, hypersalivation, dry mouth, hyposthesia of the oral and/or pharyngeal mucosa.

Respiratory system: rhinorrhea, dryness of the mucous membrane of the upper respiratory tract, dyspnea (as a symptom of hypersensitivity reaction).

Urinary system: dysuria.

Nervous system: dysgeusia (disturbance of taste sensation).

Immune system, skin and subcutaneous tissues: itching, rash, urticaria, anaphylactic reactions (including angioneurotic edema, anaphylactic shock), fever, chills, other allergic reactions.

Very rarely, severe skin reactions may occur, such as erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, acute generalized exanthematous pustulosis.

Other: reactions involving mucous membranes.

Shelf life. 3 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

In the original packaging at a temperature not exceeding 25 °C. After opening the bottle, the shelf life of the drug is 30 days at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

50 ml in a bottle, 1 bottle with a dosing spoon in a carton. 100 ml in bottles and jars, 1 bottle or 1 jar with a dosing spoon in a carton. 120 ml in bottles and jars, 1 bottle or 1 jar with a dosing spoon in a carton.

Prescription status. Over-the-counter.

Manufacturer.

Public Joint-Stock Company "Scientific and Production Center "Borshchahivskiy Chemical and Pharmaceutical Plant".

Manufacturer's address and place of business.

17, Miru Street, Kyiv, 03134, Ukraine.